MAH Essentials: Ensuring Compliance for European Market Entry
Learn key responsibilities of MAAs, MAHs, and QPs in the EEA/UK, ensuring you achieve successful
European market access.
Date: July 10, 2025
Time: 10:00-11:00AM US EST / 4:00-5:00 PM CEST
About the Webinar
Join us for an in-depth webinar that explores the critical responsibilities and challenges faced by Marketing Authorization Applicants (MAAs), Marketing Authorization Holders (MAHs), and Orphan Designation Holders in the European Economic Area (EEA) and United Kingdom (UK).
Our regulatory, pharmacovigilance, and quality and compliance experts will share key insights and practical strategies to help you ensure compliance and facilitate smooth market access in Europe. They'll talk you through the different phases that are required, from applying a first marketing authorization in Europe, through approval of the marketing authorization, until launching the product.
You’ll gain a clear understanding of the European pharmacovigilance (PV) system requirements, the lifecycle from initial marketing authorization application to product launch, and the pivotal role of the Qualified Person (QP) in ensuring regulatory success.
What You Will Learn
- Legal entity establishment and the roles/responsibilities of MAAs and MAHs in the EEA and UK
- Core PV system requirements for MAHs in Europe
- QP declaration requirements at dossier submission
- QP certification responsibilities at the time of batch release
Who Should Attend?
This webinar is ideal for professionals in the pharmaceutical and biotech sectors, especially those in:
- Pharmacovigilance
- Regulatory Affairs
- Clinical Development
- Commercial Operations
It’s especially relevant for managers, decision-makers, and team leaders overseeing or involved in regulatory and market access strategies.
Unable to join? Register and you will receive the recording after the live session.
Meet the Speakers
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Frank de Vries
Vice President, Strategy, Regulatory Sciences – Development
View Bio
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Eleonora Casucci
Vice President, Quality & Compliance EU/UK/India and CEO of ProPharma MIA License B.V.
View Bio
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Thomas Chatzopoulos
Vice President, QPPV Office
View Bio
Frank de Vries
Frank has over 30 years of experience in industry in a broad Regulatory Scientific field across all product types and multiple therapeutic areas including (pediatric) rare diseases and leads a team of subject matter experts in Regulatory Sciences to advise, support or lead overall regulatory strategy development and execution.
Frank’s broad and varied experience within the drug development industry includes significant interaction with the European Medicines Agency (EMA) and majority of national regulatory agencies across Europe, Middle East, CIS Region, Africa and to a certain extent LATAM, APAC, Canada, Australia, US. Regulatory interactions include but are not limited to scientific advice/protocol assistance, orphan applications and maintenance, pediatric investigation plans, early interactions, pre-submission meetings with EMA and/or Rapp/Co-Rapp and full marketing authorisation application pre-submission and full procedural support.
Frank has led various due diligence activities for product or portfolio acquisition and supported various Mergers & Acquisitions and served as international expert witness in arbitration court cases. Aside from Regulatory Scientific experience, Frank also held positions in Business Development, In/out-licensing, Commercial, Marketing & Sales, Quality and Pharmacovigilance.